DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to parent Application No. JP2021-160406, filed on 30 September 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 May 2024 & 31 January 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of the claims corresponding to constructional features of the ultrasonic, sonic or infrasonic diagnostic device (A61B 8/44) along with generic Claims 1 & 20 in the reply filed on 23 July 2025 is acknowledged. Since Applicant failed to identify the claims corresponding to the elected to species, the Office identifies Claim 18 as corresponding to the species regarding constructional features of the ultrasonic, sonic or infrasonic diagnostic device (A61B 8/44).
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: ULTRASONIC AND OPTICAL ENDOSCOPE SYSTEM AND METHOD OF OPERATING ULTRASONIC AND OPTICAL ENDOSCOPE SYSTEM.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1 recites “an endoscope operation part that is operated by a user” which includes the generic placeholder “endoscope operation part” coupled to functional language “that is operated by a user” without reciting sufficient structure to achieve the function. For the purpose of this Examination, the broadest reasonable interpretation of the claim limitation is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act. In particular, in FIG. 1 of the instant specification, the endoscope operation part 3 is illustrated as a handle portion; and
Claim 1 recites “an endoscope insertion part that is connected to the endoscope operation part and is to be inserted into a subject” which includes the generic placeholder “endoscope insertion part” coupled to functional language “to be inserted into a subject” without reciting sufficient structure to achieve the function. For the purpose of this Examination, the broadest reasonable interpretation of the claim limitation is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act. In particular, in FIG. 1 of the instant specification, the endoscope insertion part 4 is illustrated as a cannula portion.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 18, & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu (WO 2021/090056 A1; see IDS of 31 January 2025).
With regards to Claim 1, Yu discloses an ultrasonic endoscope system (combined ultrasound and endoscopy systems; Yu ¶ [0031])comprising:
an endoscope operation part that is operated by a user (lower multiple-use handle portion 130; see Yu FIG. 2A & ¶ [0036]);
an endoscope insertion part that is connected to the endoscope operation part and is to be inserted into a subject (cannula 240 attached to lower multiple-use handle portion 130 via upper housing 130; see Yu FIG. 2A & ¶ [0035]);
an ultrasonic transducer array that is disposed at a distal end of the endoscope insertion part (ultrasound probe head 252 with a plurality of transducer elements {i.e. array} clearly illustrated at distal end 250 in Yu FIG. 2A; see also Yu ¶ [0036]);
an endoscope image processor section that generates an endoscope image based on an image signal acquired optically by the endoscope insertion part (processor 274 {in lower multiple-use handle portion 130 } transmits filtered raw image data to hysteroscope image processing unit 180 {i.e. endoscope image processor section}; see Yu ¶ [0040] & FIGS. 1A & 2A);
an ultrasound image processor section that is housed in the endoscope operation part and generates ultrasound image information data by performing signal processing on a reception signal output from the ultrasonic transducer array (ultrasound processing unit 182 {of FIG. 1A} can be separated from processing system 170 such as ultrasound processing unit 272 in handle 130; see Yu ¶ [0036] & FIG. 2A); and
a display unit that displays an ultrasound image based on the ultrasound image information data and the endoscope image (display 150 configured to display ultrasound images; see Yu ¶ [0031] & FIG. 1A).
Claim 20 recites similar limitations and are rejected under the same rationale as Claim 1.
With regards to Claim 181,
wherein the endoscope operation part has an operation member and a control substrate for controlling the operation member (handle portion 130 includes one or more buttons 212 can be programmed to control LED lighting level (of LEDs at the distal tip 250), capture still images and/or start and stop recording to video images, and capture and/or start and stop recording to ultrasound data and/or ultrasound images; see Yu FIG. 2A & ¶ [0037]; it should be appreciated that the programmed button would be understood by one of ordinary skill in the art as being operatively connected to a circuit board to perform anyone one of the “control[ling]” operations detailed), and
the ultrasound image processor section is mounted on the control substrate (it should be appreciated that one of ordinary skill in the art would understand that in order for the button(s) 212 to be able to control the “capture and/or start and stop recording to ultrasound data and/or ultrasound images” that said buttons would be operatively in communication {i.e. transmission means between button and processor amounts to a control substrate} with said processor 272).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798